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Insulin aspart

Generic Name
Insulin aspart
Brand Names
Fiasp, Novolog, Novolog Mix, Novomix, Novorapid, Novorapid Penfill, Ryzodeg, Truvelog Mix 30, Kirsty (previously Kixelle), NovoRapid, Insulin aspart Sanofi, NovoMix
Drug Type
Biotech
CAS Number
116094-23-6
Unique Ingredient Identifier
D933668QVX

Overview

Insulin aspart is a rapid-acting form of insulin used for the treatment of hyperglycemia caused by Type 1 and Type 2 Diabetes. Insulin is typically prescribed for the management of diabetes mellitus to mimic the activity of endogenously produced human insulin, a peptide hormone produced by beta cells of the pancreas that promotes glucose metabolism. Insulin is released from the pancreas following a meal to promote the uptake of glucose from the blood into internal organs and tissues such as the liver, fat cells, and skeletal muscle. Absorption of glucose into cells allows for its transformation into glycogen or fat for storage. Insulin also inhibits hepatic glucose production, enhances protein synthesis, and inhibits lipolysis and proteolysis among many other functions. Insulin is an important treatment in the management of Type 1 Diabetes (T1D) which is caused by an autoimmune reaction that destroys the beta cells of the pancreas, resulting in the body not being able to produce or synthesize the insulin needed to manage circulating blood sugar levels. As a result, people with T1D rely primarily on exogenous forms of insulin, such as insulin aspart, to lower glucose levels in the blood. Insulin is also used in the treatment of Type 2 Diabetes (T2D), another form of diabetes mellitus that is a slowly progressing metabolic disorder caused by a combination of genetic and lifestyle factors that promote chronically elevated blood sugar levels. Without treatment or improvement in non-pharmacological measures such as diet and exercise to lower blood glucose, high blood sugar eventually causes cellular resistance to endogenous insulin, and in the long term, damage to pancreatic islet cells. Insulin is typically prescribed later in the course of T2D, after trying several oral medications such as Metformin, Gliclazide, or Sitagliptin have been tried, when sufficient damage has been caused to pancreatic cells that the body is no longer able to produce insulin on its own. Marketed as the brand name product NovoRapid, insulin aspart begins to exert its effects within 15 minutes of subcutaneous administration, while peak levels occur 30 to 90 minutes after administration. Due to its duration of action of around 5 hours, NovoRapid is considered "bolus insulin" as it provides high levels of insulin in a short period of time to mimic the release of endogenous insulin from the pancreas after meals. Bolus insulin is often combined with once daily, long-acting "basal insulin" such as Insulin detemir, Insulin degludec, and Insulin glargine to provide low concentrations of background insulin that can keep blood sugar stable between meals or overnight. Use of basal and bolus insulin together is intended to mimic the pancreas' production of endogenous insulin, with a goal of avoiding any periods of hypoglycemia. Insulin aspart is a recombinant, biosynthetic, fast-acting insulin analogue. Compared to human insulin, it has a single amino acid substitution at position B28 where proline is replaced with aspartic acid. This substitution decreases its propensity to form hexamers and gives it a higher rate of absorption following subcutaneous administration compared to native insulin. Insulin aspart is produced in a genetically modified strain of Saccharomyces cerevisiae (baker's yeast) Without an adequate supply of insulin to promote absorption of glucose from the bloodstream, blood sugar levels can climb to dangerously high levels and can result in symptoms such as fatigue, headache, blurred vision, and increased thirst. If left untreated, the body starts to break down fat, instead of glucose, for energy which results in a build-up of ketone acids in the blood and a syndrome called ketoacidosis, which is a life-threatening medical emergency. In the long term, elevated blood sugar levels increase the risk of heart attack, stroke, and diabetic neuropathy.

Indication

Insulin aspart is indicated to improve glycemic control in adults and children with diabetes mellitus.

Associated Conditions

  • Diabetes Mellitus
  • Diabetic Ketoacidosis
  • Gestational Diabetes Mellitus (GDM)
  • Hyperglycemia during critical illness

Research Report

Published: Jul 10, 2025

An In-Depth Monograph on Insulin Aspart (DB01306): From Molecular Engineering to Clinical Practice

Executive Summary

Insulin aspart (DrugBank ID: DB01306) represents a cornerstone therapy in the management of diabetes mellitus. As a rapid-acting, recombinant human insulin analog, its development marked a significant milestone in biotechnology and rational drug design. The therapeutic innovation of insulin aspart is rooted in a single, targeted amino acid substitution—the replacement of proline with aspartic acid at position B28 of the insulin B-chain. This seemingly minor modification profoundly alters the molecule's physicochemical properties, reducing its propensity to form hexamers and enabling significantly faster absorption from subcutaneous tissue compared to regular human insulin. This accelerated pharmacokinetic profile translates directly into a more physiological pharmacodynamic response, allowing for effective control of postprandial glucose excursions when administered immediately before meals.

Clinically, insulin aspart is indicated for improving glycemic control in both Type 1 and Type 2 diabetes mellitus in adults and children. It is administered via subcutaneous injection, continuous subcutaneous infusion via an insulin pump, or intravenously in supervised clinical settings. Its efficacy is well-established, though its primary advantage, particularly in Type 2 diabetes, often lies in the enhanced convenience and quality of life it offers patients over older insulins. The safety profile is well-characterized and dominated by the risk of hypoglycemia, a direct extension of its glucose-lowering pharmacology.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/22
Not Applicable
Not yet recruiting
2025/07/16
Not Applicable
Not yet recruiting
2025/02/05
Phase 1
Recruiting
2024/08/19
Phase 2
Recruiting
Gan and Lee Pharmaceuticals, USA
2024/08/09
Early Phase 1
Recruiting
Anna Stanhewicz, PhD
2024/08/01
Not Applicable
Recruiting
2024/01/10
Phase 2
Completed
Gan and Lee Pharmaceuticals, USA
2023/11/13
Phase 4
Recruiting
Sun Yat-sen University
2023/07/14
Early Phase 1
Recruiting
Anna Stanhewicz, PhD
2023/07/14
Early Phase 1
Recruiting
Anna Stanhewicz, PhD

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Novo Nordisk
0169-3205
SUBCUTANEOUS
100 [iU] in 1 mL
6/21/2023
Sanofi-Aventis U.S. LLC
0024-5927
SUBCUTANEOUS, INTRAVENOUS
100 [iU] in 1 mL
5/30/2025
A-S Medication Solutions
50090-4085
SUBCUTANEOUS
100 [iU] in 1 mL
4/28/2021
Novo Nordisk Pharma, Inc.
73070-102
INTRAVENOUS, SUBCUTANEOUS
100 [iU] in 1 mL
11/15/2019
Novo Nordisk
0169-3696
SUBCUTANEOUS
100 [iU] in 1 mL
4/28/2021
Novo Nordisk Pharma, Inc.
73070-203
SUBCUTANEOUS
100 [iU] in 1 mL
10/30/2020
Physicians Total Care, Inc.
54868-5201
SUBCUTANEOUS
100 [iU] in 1 mL
6/15/2011
Novo Nordisk
0169-2101
INTRAVENOUS, SUBCUTANEOUS
100 [iU] in 1 mL
2/28/2023
Novo Nordisk
0169-2200
SUBCUTANEOUS
100 [iU] in 1 mL
4/28/2021
REMEDYREPACK INC.
70518-3236
SUBCUTANEOUS
100 [iU] in 1 mL
3/14/2024

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
RYZODEG FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 100U/ML 70/30 3ML
N/A
novo nordisk hong kong ltd.
N/A
N/A
4/28/2025

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
NOVOMIX 30 PENFILL 3mL 30% soluble insulin aspart (rys) and 70% insulin aspart (rys) crystallised with protamine 300U/3mL injection cartridge
143165
Medicine
A
6/5/2008
RYZODEG 70/30 PENFILL 70% insulin degludec (rys) / 30% insulin aspart (rys) 100 U/mL solution for injection cartridge
280433
Medicine
A
11/29/2017
FIASP FLEXTOUCH insulin aspart (rys) 100 units/mL solution for injection 3 mL pre-filled pen
275394
Medicine
A
7/27/2017
RYZODEG 70/30 FLEXTOUCH 70% insulin degludec (rys) / 30% insulin aspart (rys) 100 U/mL solution for injection cartridge
280432
Medicine
A
11/29/2017
NOVORAPID FLEXPEN insulin aspart (rys) 300U/3mL injection multidose cartridge
133445
Medicine
A
12/21/2006
NOVOMIX 30 FLEXPEN 3mL 30% soluble insulin aspart (rys) and 70% insulin aspart (rys) crystallised with protamine 300U/3mL injection syringe
143166
Medicine
A
6/5/2008
NOVORAPID PENFILL insulin aspart (rys) 300U/3mL injection cartridge
133444
Medicine
A
12/21/2006
NOVORAPID FLEXTOUCH insulin aspart (rys) 300U / 3mL injection multidose cartridge
188334
Medicine
A
8/7/2012
NOVORAPID insulin aspart (rys) 100U/mL injection multidose vial
133443
Medicine
A
12/21/2006
FIASP PENFILL insulin aspart (rys) 100 units/mL solution for injection 3 mL cartridge
275393
Medicine
A
7/27/2017

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
KIRSTY
biocon sdn.bhd
02520974
Solution - Subcutaneous
100 UNIT / ML
10/20/2022
TRURAPI
sanofi-aventis canada inc
02506564
Solution - Subcutaneous
100 UNIT / ML
3/30/2021
NOVORAPID
Novo Nordisk Canada Inc
02377209
Solution - Subcutaneous
100 UNIT / ML
5/4/2012
NOVORAPID
Novo Nordisk Canada Inc
02245397
Solution - Subcutaneous
100 UNIT / ML
6/12/2002
FIASP
Novo Nordisk Canada Inc
02460408
Solution - Subcutaneous
100 UNIT / ML
3/3/2017
NOVOMIX 30
Novo Nordisk Canada Inc
02265435
Suspension - Subcutaneous
70 UNIT / ML
9/12/2005
NOVOMIX 30
Novo Nordisk Canada Inc
02265435
Suspension - Subcutaneous
30 UNIT / ML
9/12/2005
FIASP
Novo Nordisk Canada Inc
02460416
Solution - Subcutaneous
100 UNIT / ML
3/3/2017
NOVOMIX 30 (FLEXPEN)
Novo Nordisk Canada Inc
02265443
Suspension - Subcutaneous
30 %
N/A
NOVOMIX 30 (FLEXPEN)
Novo Nordisk Canada Inc
02265443
Suspension - Subcutaneous
70 %
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
FIASP 100 UNIDADES/ML FLEXTOUCH SOLUCION INYECTABLE EN PLUMA PRECARGADA
1161160001
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
RYZODEG 100 UNIDADES/ML SOLUCION INYECTABLE EN PLUMA PRECARGADA
12806001
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
NOVOMIX 30 FLEXPEN 100 U/ML SUSPENSION INYECTABLE EN UNA PLUMA PRECARGADA
00142009
SUSPENSIÓN INYECTABLE EN JERINGA PRECARGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
NOVOMIX 50 FLEXPEN 100 U/ML SUSP. INYECTABLE EN UNA PLUMA PRECARGADA
00142015
SUSPENSIÓN INYECTABLE EN JERINGA PRECARGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
FIASP 100 UNIDADES/ML PUMPCART SOLUCION INYECTABLE EN CARTUCHO
1161160012
SOLUCIÓN INYECTABLE EN CARTUCHO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
NOVOMIX 70 FLEXPEN 100 U/ML SUSP. INYECTABLE EN UNA PLUMA PRECARGADA
00142021
SUSPENSIÓN INYECTABLE EN JERINGA PRECARGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
NOVORAPID 100 U/ML SOLUCION INYECTABLE EN VIAL
99119001
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
NOVORAPID PENFILL 100 U/ML SOLUCION INYECTABLE EN CARTUCHO
199119003
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
FIASP 100 UNIDADES/ML SOLUCION INYECTABLE EN VIAL
1161160007
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
NOVORAPID FLEXPEN 100 U/ML SOLUCION INYECTABLE EN UNA PLUMA PRECARGADA
99119009
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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